Metoclopramide for Migraine: A Dose Finding Study (MDFS)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: metoclopramide; Drug: Diphenhydramine 25mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00682734

07-11-405

Details and patient eligibility

About

Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Full description

Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Enrollment: 349 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute migraine

Exclusion criteria

• secondary cause of headache
• lumbar puncture
• allergy or intolerance to study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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349 participants in 3 patient groups

1

Active Comparator group

Description:

Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes

Treatment:

Drug: metoclopramide

Drug: metoclopramide

Drug: metoclopramide

Drug: Diphenhydramine 25mg

2

Experimental group

Description:

metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.

Treatment:

Drug: metoclopramide

Drug: metoclopramide

Drug: metoclopramide

Drug: Diphenhydramine 25mg

3

Experimental group

Description:

metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.

Treatment:

Drug: metoclopramide

Drug: metoclopramide

Drug: metoclopramide

Drug: Diphenhydramine 25mg